FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,110 results
4009–4032 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Mar 19, 2014
EMBOL-X INTRODUCER SHEATH
K140398 · DYB
Edwards Lifesciences, LLC
Cardiovascular · 29d
Cleared Mar 19, 2014
MELYS ATRIAL FIBRILLATION SCREENING MONITOR
K132206 · DXH
Advanced Fluidics, LLC
Cardiovascular · 246d
Cleared Mar 18, 2014
ASAHI GAIA FIRST, SECOND, THIRD
K133865 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 89d
Cleared Mar 14, 2014
HEALTHINTERLINK BEACON
K133252 · DRG
Healthinterlink, LLC
Cardiovascular · 143d
Cleared Mar 12, 2014
SOUNDSTAR ECO 8F GULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER
K140318 · OBJ
Biosense Webster
Cardiovascular · 30d
Cleared Mar 11, 2014
ULTIMUM EV HEMOSTASIS INTRODUCER
K140327 · DYB
St Jude Medical
Cardiovascular · 29d
Cleared Mar 11, 2014
BPROSOFT CASP PC SOFTWARE
K131916 · DXN
Healthstats International Pte. , Ltd.
Cardiovascular · 258d
Cleared Mar 07, 2014
OPTEASE VENA CAVA FILTER AND OPTEASE RETRIEVAL CATHTETER
K140286 · DTK
Cordis, A Johnson & Johnson Co.
Cardiovascular · 30d
Cleared Mar 06, 2014
CATHETER INTRODUCER SHEATH
K131627 · DYB
Edwards Lifesciences, LLC
Cardiovascular · 275d
Cleared Mar 05, 2014
FERM-FLEX AND FEM-FLEX II ( FEMORAL ACCESS ARTERIAL CANNULAE) FEMTRAK,VFEM,...
K140208 · DWF
Edwards Lifesciences, LLC
Cardiovascular · 36d
Cleared Mar 05, 2014
DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM18 SERIES
K133619 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 100d
Cleared Mar 05, 2014
DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM22 SERIES
K133618 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 100d
Cleared Mar 05, 2014
ANGIOVAC CANNULA
K133445 · DWF
Vortex Medical, Inc.
Cardiovascular · 113d
Cleared Mar 05, 2014
CONTEC ELECTROCARDIOGRAPH
K131900 · DPS
Contec Medical System Co., Ltd.
Cardiovascular · 253d
Cleared Mar 04, 2014
HEM-7320
K133383 · DXN
Omron Healthcare, Inc.
Cardiovascular · 120d
Cleared Mar 04, 2014
ANDON BLOOD PRESSURE CUFF
K133117 · DXQ
Andon Health Co, Ltd.
Cardiovascular · 155d
Cleared Mar 04, 2014
RITHM ID ELECTROPHYSIOLOGY CATHETER
K133028 · DRF
Synaptic Medical Limited
Cardiovascular · 159d
Cleared Mar 04, 2014
HEALTHSTATS A-PULSE CASPAL + AND MC3100+ MONITORS AND MY-BP BP MANAGEMENT...
K131788 · DXN
Healthstats International Pte. , Ltd.
Cardiovascular · 259d
Cleared Feb 28, 2014
DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
K133999 · MCW
Cardiovascular Systems, Inc.
Cardiovascular · 63d
Cleared Feb 28, 2014
FLOWTRON ACS800 PUMP AND TRI PULSE GARMENTS
K133119 · JOW
Arjohuntleigh Polska SP Z.O.O.
Cardiovascular · 151d
Cleared Feb 28, 2014
GLADIATOR ELITE PTA BALLOON DILATATION CATHETER
K132810 · LIT
Boston Scientific Corp
Cardiovascular · 172d
Cleared Feb 27, 2014
SARNS SOFT-FLOW EXTENDED AORTIC CANNULA
K132811 · DWF
Terumo Cardiovascular Systems...
Cardiovascular · 171d
Cleared Feb 27, 2014
M SERIES PATIENT MONITOR
K131876 · MHX
Mid-Link Consulting Co, Ltd.
Cardiovascular · 248d
Cleared Feb 26, 2014
SUREFIRE GUIDING CATHETER
K140034 · DQY
Surefire Medical, Inc.
Cardiovascular · 50d